510(k) K260652
- Device
- ColActive Plus
- Applicant
- Covalon Technologies, Ltd.
- 510(k) number
- K260652
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-09
- Date received
- 2026-02-27
- Classification name
- Wound Dressing With Animal-Derived Material(S)
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christina Mitchell
- Address
- 1660 Tech Ave. Unit 5 Mississauga CA L4W 5S7 L4W 5S7
FDA Registration Numbers#
- 3043861816
- 1720734
- 3010097129
- 8043792
- 3015058854
- 3017399129
- 3010824458
- 1645368
- 3042750477
- 3030067857
- 1650372
- 2530154
- 3015282703
- 2431866
- 3002636527
- 3016429246
- 3027448274
- 2030598
- 3013820501
- 9680579
- 2245539
- 1066741
- 2249852
- 1648579
- 3014498807
- 3012448339
- 3014146451
- 1225991
- 3012535730
- 3007738736
- 3039169663
- 3006802076
- 8043396
- 1417592
- 3004431266
- 3010187826
- 3010155661
- 1531062
- 1835959
- 3007663067
- 3004189237
- 2024024
- 1058584
- 3003300673
- 3016904853
- 3010668881
- 3018348
- 3011680766
- 3009109670
- 1060680
- 3005433617
- 3002907620
- 3017660750
- 3034456223
- 3015442987
- 3007735241
- 3007321028
- 3011276344
- 2135152
- 3005920706
- 3011649314
- 9614442
- 3036710971
- 3012102437
- 3042708438
- 3017633586
- 3014820861
- 3015946784
- 3017391151
- 3009317711
- 2245437
- 3003768919
- 1043214
- 3003418325
- 2435946
- 3012940386
- 3014982332
- 1047843
- 3004799623
- 3004713654
Source Documents#
Other 510(k) Records For Product Code KGN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260920 | Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA) | Berkeley Advanced Biomaterials | 2026-10-22 |
| K260530 | epi-ConneKt™ Wound Matrix | MLM Biologics, Inc. | 2026-10-15 |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials | 2026-08-27 |
| K260596 | Collagen Wound Powder | Ventris Medical | 2026-07-02 |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | 2026-06-24 |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | 2026-06-18 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 2026-02-19 |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 2026-02-10 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 |
| K252673 | LacertaMatrix | Lacerta Life Science | 2025-12-22 |